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Publishing of Clinical Trial and Regulatory Submission Documents

Regulatory Publishing Expertise to Support Electronic Submissions to Regulatory Authorities

Health Authorities around the world are requiring that all clinical trial documentation, as well as regulatory and marketing applications be submitted electronically. This improves the efficiency of delivery, formatting, and review of the files, documentation, and applications submitted. 

Sponsors sometimes fail to understand the time and effort involved in pre-flighting and publishing their submissions to regulatory agencies (i.e., submitting to the FDA over the electronic submissions gateway (ESG)). At Veristat, we understand the critical nature of publishing to health authorities and that is why we’ve assembled an experienced team of regulatory publishers who average 10-14 years of industry publishing experience.

Ensure a successful regulatory submission process.

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In the past year

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Sponsors supported with publishing of INDs, clinical trial documents and marketing applications

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INDs published

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Marketing Applications published

Overcoming Regulatory Publishing Challenges

Our regulatory publishing experts will help you establish realistic timelines and best practices for publishing single documents or full marketing applications. Using the right publishing team that is fully integrated with your regulatory and writing teams can help you find efficiencies to reduce timelines. Whether you are just beginning your development process or are not happy with your current publishing partner – we can help.

All submissions are electronically published to regulatory agencies using an industry-leading technology platform with templates that our publishers have customized to meet the real-world needs of our customers.

A Proven Regulatory Publishing Process

Archive

Archive and transfer final word docs and submission

Pre-Publish

Document-level processing. Includes document formatting in our templates as mentioned, converting to PDF, and ensuring the appropriate bookmarks and internal hyperlinks are present to meet eCTD guidance

QC

Perform document-level QC prior to eCTD build. Performed by a secondary publisher

eCTD Build

Place documents into respective sections within the eCTD structure. Create hyperlinks between documents, ensure completeness of submission

QC

QC of external hyperlinks, document file tags, and general completeness of submission. Performed by a secondary publisher

Review

Client review/approval of submission. We can also engage our Regulatory Strategists for this part

Submit

Push the actual transmission through the appropriate health authority gateway or portals

Archive

Archive and transfer final word docs and submission

NDA Publishing CS

 

Case Study: The Power of Publishing for an Efficient Submission Process

An IND was transferred to Veristat from another vendor during the critical regulatory registration stage, and virtually all the content provided needed substantive review and modification to meet data submission requirements. Read the full case study to learn how Veristat supported the Sponsor through to successful submission and FDA approval.

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Expert Regulatory Filings Throughout the Entire Development Journey

Our team of regulatory publishers offers end-to-end publishing support for your program from a regulatory, CMC, and clinical perspective.  They write and submit the following types of dossiers/documents, including:
  • Full INDs 
  • Investigator Brochures (IBs)/Documents
  • Protocols
  • Briefing Books/Agency Meeting Requests
  • Protocols/Amendments
  • Safety Updates
  • SAEs
  • Clinical Study Reports (CSRs)
  • Clinical Trial Datasets/DMFs
  • Briefing Books/Agency Meeting Requests
  • Expedited Pathway/designation applications
  • Marketing Applications (NDAs, BLAs, MAAs, etc)
  • Annual Reports/DSURs
  • Periodic/Yearly Safety updates 
  • Advertising Promotions
  • Risk Management Plans

HubDB_Card Image_Podcast_S3E4Podcast: Best Practices for Publishing Marketing Applications

When it comes to submitting your marketing application, using the right publishing team can save you time on the overall preparation and medical experts. In this episode of Advancing Revolutionary Therapies, Veristat regulatory experts discuss marketing application best practices from a publishing perspective, and strategies to consider when planning your marketing application.

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Underestimating your publishing timeline can cause delays – speak with our experts

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Learn More with These Resources

Blog

Monthly FDA Guidance and Regulatory News Review - April 2024

Case Study

Advancing to Your Next Milestone – Global Regulatory ...

Blog

Regulatory Guidance Monthly Review - February 2024